Analyte monitoring device and methods

ABSTRACT

Method and system for determining real time analyte concentration including an analyte sensor having a portion in fluid contact with an interstitial fluid under a skin layer, an on-body electronics including a housing coupled to the analyte sensor and configured for positioning on the skin layer, the on-body electronics housing including a plurality of electrical contacts , on the housing; and a data analysis unit having a data analysis unit housing and a plurality of probes , on the housing. Each of the probes configured to electrically couple to a respective electrical contact when the data analysis unit is positioned in physical contact with the on-body electronics. The one or more signals on the probes correspond to one or more of a substantially real time monitored analyte concentration level (MACL), MACL over a predetermined time period, or a rate of change of the MACL, or combinations thereof, are provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority based on U.S. Provisional ApplicationNo. 61/325,260, filed Apr. 16, 2010 and U.S. Provisional Application No.61/422,460, filed Dec. 13, 2010, the disclosures of which are hereinincorporated by reference in their entirety.

This application is related to U.S. patent application Ser. No.12/393,921, filed Feb. 26, 2009; U.S. patent application Ser. No.12/807,278, filed Aug. 31, 2010; U.S. patent application Ser. No.12/876,840, filed Sep. 7, 2010; U.S. Provisional Application No.61/325,155, filed Apr. 16, 2010; and U.S. Provisional Application No.61/247,519, filed Sep. 30, 2009. The disclosures of the above-mentionedapplications are incorporated herein by reference in their entirety.

BACKGROUND

Diabetes Mellitus is an incurable chronic disease in which the body doesnot produce or properly utilize insulin. Insulin is a hormone producedby the pancreas that regulates blood glucose. In particular, when bloodglucose levels rise, e.g., after a meal, insulin lowers the bloodglucose levels by facilitating blood glucose to move from the blood intothe body cells. Thus, when the pancreas does not produce sufficientinsulin (a condition known as Type 1 Diabetes) or does not properlyutilize insulin (a condition known as Type II Diabetes), the bloodglucose remains in the blood resulting in hyperglycemia or abnormallyhigh blood sugar levels.

People suffering from diabetes often experience long-term complications.Some of these complications include blindness, kidney failure, and nervedamage. Additionally, diabetes is a factor in acceleratingcardiovascular diseases such as atherosclerosis (hardening of thearteries), which often leads stroke, coronary heart disease, and otherdiseases, which can be life threatening.

The severity of the complications caused by both persistent high glucoselevels and blood glucose level fluctuations has provided the impetus todevelop diabetes management systems and treatment plans. In this regard,diabetes management plans historically included multiple daily testingof blood glucose levels typically by a finger-stick to draw and testblood. The disadvantage with finger-stick management of diabetes is thatthe user becomes aware of his blood glucose level only when he performsthe finger-stick. Thus, blood glucose trends and blood glucose snapshotsover a period of time is unknowable. More recently, diabetes managementhas included the implementation of glucose monitoring systems. Glucosemonitoring systems have the capability to continuously monitor a user'sblood glucose levels. Thus, such systems have the ability to illustratenot only present blood glucose levels but a snapshot of blood glucoselevels and blood glucose fluctuations over a period of time.

SUMMARY

Embodiments of the present disclosure includes a transcutaneouslypositionable analyte sensor in signal communication with electronicswhich process signals from the analyte sensor transfer or otherwiseprovide the processed signals related to monitored analyte level to areceiver unit, a blood glucose meter or other devices configured toreceive, process, analyze, output, display and/or store the processedsignals. Embodiments of the analyte monitoring systems include in vivoanalyte sensors in fluid contact with body fluid such as interstitialfluid to monitor the analyte level such as glucose. Embodiments includeelectronics and/or data processing, storage and/or communicationcomponents that are electrically coupled to the analyte sensor, and mayinclude a housing that is placed or positioned on the body surface suchas on the skin surface and adhered thereon with an adhesive and retainedand maintained in the adhered position for the duration of the analytemonitoring time period using the analyte sensor such as, for example,about 15 days or more, about 10 days or more, about 7 days or more, orabout 5 days or more, or about 3 days or more. The housing including theelectronics and/or data processing, storage and/or data communicationcomponents may be positioned on discrete on-body locations includingunder clothing during the duration of the monitoring time period. Theanalyte monitoring device that is coupled to the body and includes thetranscutaneously positionable analyte sensor, housing, and electronicsand/or data processing, storage and/or communication components, is alsoreferred to herein as an “on-body unit”, “OBU”, “on body patch”, or“patch”.

The particular profile, as well as the height, width, length, weight,and volume of the housing may vary and depends, at least in part, on thecomponents and associated functions included in the OBU. In general, theOBU includes a housing typically formed as a single integral unit thatrests on the skin of the patient. The housing typically contains most orall of the electronic components of the OBU. The housing may be madefrom a variety of materials such as, but not limited to, metal,metal-alloys, natural or synthetic polymers, etc. For example, plasticssuch as rigid thermoplastics and engineering thermoplastics may be used.Additional examples of suitable materials include, for instance,polyvinyl chloride, polyethylene, polypropylene, polystyrene, ABSpolymers, and copolymers thereof. The housing of the OBU may be formedusing a variety of techniques including, for example, injection molding,compression molding, casting, and other molding methods.

Embodiments include the housing of the on body patch or housing of theelectronics that is water proof such that the user or the patientwearing the housing on a discrete on-body location may swim, shower,exercise or otherwise engage in daily activities with comfort andwithout inconvenience. Embodiments include the adhesive provided on thebottom surface of the housing in contact with the skin surface thatretains the housing in position on the skin surface during the durationof the analyte monitoring time period discussed above.

Embodiments of the present disclosure include electrical contacts on thesurface of the housing that includes the electronics and/or dataprocessing, storage and/or communication components which areelectrically coupled to the analyte sensor such that when electricalcontacts or probes provided on the receiver unit or the blood glucosemeter are in physical contact with the corresponding electrical contactson the surface of the housing that includes the electronics and/or dataprocessing, storage and/or communication components, signals associatedwith the monitored analyte level by the analyte sensor are acquired bythe receiver unit or the blood glucose meter. The receiver unit may alsobe referred to herein as “reader” or “reader unit”. As described above,the reader may be an analyte monitoring device that is brought incontact with the OBU to acquire readings from the OBU. The reader maybe, for example, an analyte meter (e.g., blood glucose meter), a mobiledevice that has been adapted to receive readings from the OBU, etc.

Details of embodiments including analyte data acquisition by physicallycontacting or touching the housing of the sensor electronics with thereader or the blood glucose meter is provided in U.S. ProvisionalApplication No. 61/247,519, the disclosure of which is incorporatedherein by reference for all purposes. In this manner, embodiments of thepresent disclosure include analyte data acquisition or ability to obtainreal time glucose data by physically touching or contacting the readeror the blood glucose meter to the housing of the electronics and/or dataprocessing, storage and/or communication components.

Embodiments of the present disclosure include analyte sensors that areself-powered such that an external power source such as a battery isunnecessary to have the analyte sensor generate a signal that isproportional to the monitored analyte concentration. Detaileddescription of embodiments of such self-powered sensor is provided inU.S. patent application Ser. No. 12/393,921 filed Feb. 26, 2009, thedisclosure of which is incorporated herein by reference for allpurposes. The absence of the external power source such as a battery (orthe reduction in size of the external power source required) providesembodiments of the present disclosure with the size and/or the formfactor of the housing for the electronics and/or data processing,storage and/or communication components to be small (for example,approximately the size of a dime—about 18 mm in diameter) that iscomfortable to wear on the skin surface during the approximately 10 daysof wear on the skin surface.

Embodiments of the present disclosure include real time analyte dataacquisition by physical contact between the reader or the blood glucosemeter and the on body housing coupled to the analyte sensor, wheresignals are provided to the reader or the blood glucose meter that areassociated with the real time analyte concentration (such as the realtime glucose value) and/or monitored analyte concentration trendinformation for a predetermined time period (such as for example, thepast 3 hours of glucose concentration that are monitored by the analytesensor and stored by the electronics and/or data processing, storageand/or communication components in the housing). Embodiments alsoinclude storing and providing trend information with the real timemonitored analyte concentration where the predetermined time period maybe about 1 hour, about 2 hours, about 5 hours or more.

INCORPORATION BY REFERENCE

The following patents, applications and/or publications are incorporatedherein by reference for all purposes: U.S. Pat. Nos. 4,545,382;4,711,245; 5,262,035; 5,262,305; 5,264,104; 5,320,715; 5,509,410;5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551; 5,822,715;5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676; 6,121,009;6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752; 6,270,455;6,284,478; 6,299,757; 6,338,790; 6,377,894; 6,461,496; 6,503,381;6,514,460; 6,514,718; 6,540,891; 6,560,471; 6,579,690; 6,591,125;6,592,745; 6,600,997; 6,605,200; 6,605,201; 6,616,819; 6,618,934;6,650,471; 6,654,625; 6,676,816; 6,730,200; 6,736,957; 6,746,582; .6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545; 6,932,892;6,932,894; 6,942,518; 7,167,818; and 7,299,082; U.S. PublishedApplication Nos. 2004/0186365; 2005/0182306; 2007/0056858; 2007/0068807;2007/0227911; 2007/0233013; 2008/0081977; 2008/0161666; and2009/0054748; U.S. patent application Ser. No. 12/131,012; Ser. No.12/242,823; Ser. No. 12/363,712; Ser. No. 12/495,709; Ser. No.12/698,124; Ser. No. 12/699,653; Ser. No. 12/699,844; and Ser. No.12/714,439 and U.S. Provisional Application Ser. Nos. 61/230,686 and61/227,967.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 illustrates an overall system of the analyte monitoring systemincluding real time data acquisition in embodiments of the presentdisclosure;

FIG. 2 illustrates the components of an analyte monitoring system inaccordance with an embodiment of the present disclosure;

FIG. 3 illustrates the on body housing electrical contacts coupleable tothe analyte sensor electrodes in an analyte monitoring system inaccordance with an embodiment of the present disclosure;

FIG. 4 illustrates the concentric electrical contacts on the on-bodyhousing electrically coupled to the analyte sensor in embodiments of thepresent disclosure; and

FIG. 5 illustrates a circuit diagram representation of an example OBUhaving a self-powered sensor, according to certain embodiments

DETAILED DESCRIPTION

Before the present disclosure is described in additional detail, it isto be understood that this disclosure is not limited to particularembodiments described, as such may, of course, vary. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present disclosure will be limited onlyby the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges is also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

The figures shown herein are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity.

FIG. 1 illustrates an overall system of the analyte monitoring systemincluding real time data acquisition in embodiments of the presentdisclosure. Referring to FIG. 1 analyte monitoring system 100 of oneembodiment of the present disclosure is shown. In particular, as shown,in one embodiment, the on-body housing 110 is positioned or adhered tothe skin surface 120 of the user or the patient using, for example, anadhesive 131 to retain the position of the on-body housing 110 on theskin surface during the monitoring time period such as, for example,about 10 days or more. Referring to FIG. 1, as shown, when the user orthe patient wishes to determine the analyte concentration, the reader orthe blood glucose meter 140 is positioned such that it contacts ortouches the on-body housing 110 as shown. In certain embodiments, thephysical contact or touching of the on-body housing 110 with the readeror the blood glucose meter 140 transfers one or more signals from theelectronics contained within the on-body housing 110 to the reader orthe blood glucose meter 140 via electrical communication. Thetransferred or provided signals may include signals corresponding to thereal time analyte concentration level such as, for example, real timeglucose level information, monitored analyte concentration trendinformation such as, for example but not limited to, the previous threehours, the rate of change of the analyte concentration determined basedat least in part of the monitored analyte concentration trendinformation, or one or more combinations thereof.

Referring again to FIG. 1, it can be seen from the middle insert figurethat an analyte sensor 150 may be transcutaneously positioned such thata portion of the analyte sensor is positioned and retained under theskin layer during the monitoring time period of approximately, forexample, but not limited to ten days, and further, that the analytesensor 150 is coupled to the on-body housing 110 such that theelectrodes (working and counter electrodes, for example) of the analytesensor 150 are electrically coupled to one or more electrical componentsor sensor electronics in the on-body housing 110 and configured toprocess and store, among others, the signals from the analyte sensor150. Furthermore, by way of nonlimiting comparison, as discussed above,embodiments including self-powered analyte sensor which in someembodiments does not need an external power supply and the touch basedanalyte data acquisition/communication with obviates the need for awireless data communication component, permits the sizing of the on-bodyhousing 110 to be approximately the size of a dime. After the monitoringtime period, the analyte sensor 150 and/or on-body housing 110 may beremoved, disposed, and replaced.

Electrodes may be applied or otherwise processed using any suitabletechnology, e.g., chemical vapor deposition (CVD), physical vapordeposition, sputtering, reactive sputtering, printing, coating, ablating(e.g., laser ablation), painting, dip coating, etching, and the like.Materials include, but are not limited to, any one or more of aluminum,carbon (including graphite), cobalt, copper, gallium, gold, indium,iridium, iron, lead, magnesium, mercury (as an amalgam), nickel,niobium, osmium, palladium, platinum, rhenium, rhodium, selenium,silicon (e.g., doped polycrystalline silicon), silver, tantalum, tin,titanium, tungsten, uranium, vanadium, zinc, zirconium, mixturesthereof, and alloys, oxides, or metallic compounds of these elements.

FIG. 2 illustrates the components of the analyte monitoring system inaccordance with an alternative embodiment of the present disclosure.Referring to FIG. 2, as shown, embodiments include a reader or bloodglucose meter 240 that is provided with probes 211 a, 211 b, 211 cconfigured to make electrical contact with the respective one of theconcentric electrical contacts 220 on the on-body housing 210 connectedto an analyte sensor 250. As can be seen, embodiments include the probes211 a, 211 b, 211 c at a predetermined position on the housing of thereader or the blood glucose meter 240, and at a position relative toeach other such that when the reader or the blood glucose meter 240 ispositioned in contact with the on-body housing 210, each of the probes211 a, 211 b, 211 c of the reader or the blood glucose meter 240 makephysical contact with the respective one of the concentric electricalcontacts 220 on the on-body housing 210.

The analyte sensor 250 extends from the on-body housing 210 totranscutaneously position electrodes (e.g., working and counterelectrodes) on the analyte sensor 250 under the skin layer of a user.The electrodes of the analyte sensor 250 are electrically coupled to oneor more electrical components or sensor electronics in the on-bodyhousing 210. Such sensor electronics are configured to process and storethe signals from the analyte sensor 250. After the monitoring timeperiod, the analyte sensor 250 and/or on-body housing 210 may beremoved, disposed, and replaced.

Referring to FIG. 2, while embodiments include concentric electricalcontacts configuration on the on-body housing 210, in accordance withthe embodiments of the present disclosure, the electrical contacts mayinclude other shapes and sizes such as spaced apart probes, contactpads, oval shaped contacts, and any other suitable configuration toeasily establish the electrical contact with the respective of theprobes 211 a, 211 b, 211 c on the reader or the blood glucose meter 240when the reader or the blood glucose meter 240 is brought into contactwith the on-body housing 210.

It should be appreciated that the shape and position of thecorresponding contacts on the reader may vary in different embodimentsbut should enable appropriate contact with the arrangement of concentricelectrical contacts 220 when the reader is brought in contact with theOBU. The concentric shape of the electrical contacts 220 enable anon-specific orientation to be achieved. In other words, the reader maybe placed on the OBU irrespective of orientation and still providecontact with the electrical contacts on the OBU. For example, in someembodiments, the reader includes concentric electrical contacts thatline up with the concentric electrical contacts on the OBU. Forinstance, the reader may include ring-shaped concentric electricalcontacts with the same diameter as the corresponding electrical contactson the OBU. Or as another example, the reader may include electricalcontacts that are not ring shaped but disposed at the appropriatedistance to come in contact with the corresponding concentric electricalcontacts on the OBU when the reader is coupled with the OBU. Forinstance, a single contact point may be used on the reader that isdisposed at the appropriate location to align with the diameter of aring-shaped electrical contact on the OBU. In this way, regardless ofthe orientation of the reader on the OBU, the contact point will alwaysalign with the diameter of the ring-shaped electrical contact.

It should be appreciated that, in some embodiments, the reader mayinclude more than one contact for a corresponding electrical contact onthe OBU. For example, the reader may include two or more contacts thatare disposed at the appropriate location on the reader to align with thediameter of a ring-shaped concentric electrical contact. This providesadditional assurance of a good connection as well. Furthermore, itshould be appreciated that, in some embodiments, the reader may includean interface that is designed to physically mate with or “fit” with theOBU to further promote a good electrical connection.

It should also be appreciated that, in some embodiments, the concentricelectrical contacts may be disposed on the reader, and the OBU may beinclude various shaped and positioned electrical contacts that alignwith the concentric electrical contacts on the reader.

FIG. 3 illustrates the on-body housing electrical contacts coupleable tothe analyte sensor electrodes in an analyte monitoring system inaccordance with one embodiment of the present disclosure. Referring toFIG. 3, embodiments of the present disclosure include the reader or theblood glucose meter having a plurality of mating or contact sites 311 a,311 b, 311 c, 311 d, 311 e, where each of the plurality of contact sites311 a, 311 b, 311 c, 311 d, 311 e include probes to establish electricalcontact with the corresponding one of the concentric electrical contacts320 on the on-body housing 310. That is, in certain embodiments, tofacilitate alignment of the probes of the reader or the blood glucosemeter to the concentric electrical contacts 320 of the on-body housing310, the reader or the blood glucose meter may be provided with multiplecontact sites 311 a, 311 b, 311 c, 311 d, 311 e such that any one of thefive contact sites 311 a, 311 b, 311 c, 311 d, 311 e shown in FIG. 3 maytransfer the analyte sensor generated signals from to the reader or theblood glucose meter. In this way, the user may more easily couple thereader to the OBU with a successful connection since there are moreconnection sites for the user to mate the OBU with. It should beappreciated that any number of contact sites may be implemented invarious embodiments. Further, in some embodiments, the plurality ofcontact sites may be configured to cover a large portion of one side ofthe reader, to further facilitate a successful connection. For example,in some instance, the plurality of contact sites may cover 50% or moreof the reader when viewed from one side, such as 75% or more, andincluding 90% or more.

In certain embodiments, the plurality of contact sites 311 a, 311 b, 311c, 311 d, 311 e may be provided on an outer housing surface of thereader or the blood glucose meter, where each of the plurality ofcontact sites 311 a, 311 b, 311 c, 311 d, 311 e are beveled or include agroove so as to facilitate the mating with the respective concentricelectrical contacts on the on-body housing. Embodiments also includesgeometries and/or configurations of the mating sites on the reader orthe blood glucose meter and/or the on-body housing with the electricalcontacts to facilitate and/or aid the physical connection between thetwo components during analyte sensor data acquisition to determine realtime analyte concentration level and/or trend information. For example,each contact site 311 a, 311 b, 311 c, 311 d, 311 e of the reader or theblood glucose meter may include a rail or protrusion that aligns with acorresponding respective groove on the on-body housing 310 to guide,aid, and/or facilitate the alignment or proper positioning of thecontact probes on the reader or blood glucose meter to the respectiveconcentric electrical contacts on the on-body housing 310. Such a grooveon the on body housing 310 in certain embodiments may minimizeinterference and/or discomfort while wearing the on-body housing on theskin surface during the monitoring time period of for example, about tendays.

FIG. 4 illustrates the concentric electrical contacts on the on-bodyhousing electrically coupled to the analyte sensor in embodiments of thepresent disclosure. Referring to FIG. 4, embodiments include concentricelectrical contacts 421, 422, 423 each coupled to a respective node orterminal 431, 432, 433 in the electronics of the on-body housing, whichis also coupled to the analyte sensor including the working electrode451 and the counter electrode 452. As shown in FIG. 4, tworesistor-capacitor (RC) pairs R1/C1 and R2/C2 are provided in series andconnected between the working electrode 451 and the counter electrode452 of the transcutneously positionable analyte sensor. Measurements forvoltages V1 and V2 indicative of the analyte concentration detected bythe analyte sensormay be obtained by determining the voltage betweennodes 431 and 432 for voltage V1 and between nodes 432 and 433 forvoltage V2, where nodes 431, 432, and 433 are respectively coupled tothe outer concentric electrical contact 421, the middle concentricelectrical contact 422, and the inner concentric electrical contact 423as in the embodiment shown in FIG. 4.

Referring still to FIG. 4, it can be seen that the resistors R1, R2 maybe either resistors or thermistors. Embodiments include approximateresistance value of resistors R1 and R2 (or embodied as thermistors) atroom temperature (approximately 25° C.) is approximately 5 MaEmbodiments include such relatively high resistance values to increasethe voltage signal across the working and counter electrodes 451, 452.

FIG. 5 illustrates a circuit diagram representation of an example OBUhaving a self powered sensor, according to certain embodiments. Asshown, the electronics within the OBU includes two resistor-capacitor(RC) pairs 610 and 620 that are provided in series. RC pair 620 is showncomprising R1 in parallel with C1. RC pair 610 is shown comprising R2 inparallel with C1. In the example shown, resistor R1 is approximately 5MSΩ and capacitor C1 is approximately 10 μF; and resistor R2 isapproximately 5 MSΩ and capacitor C2 is approximately 94 μF. Theembodiment shown includes approximate resistance values of resistors R1and R2 at room temperature (approximately 25° C.). Some embodimentsinclude such relatively high resistance values to increase the voltagesignal across the working and counter electrodes of the analyte sensor.It should be appreciated that the values shown are exemplary and thatother values may be implemented in other embodiments. Furthermore, itshould be appreciated that C2 may be provided by one or more capacitors,and R1, R2 may be implemented as resistors or thermistors.

Node A is shown at one end of the first RC pair; node B between the twoRC pairs; and node C at the other end of the second RC pair. Currentsource 605 is shown across nodes A and C and represents the current flowprovided to circuit 600 by the analyte sensor when contactinginterstitial fluid under a skin layer, for example.

The working electrode of the analyte sensor is electrically connected tonode A, and the counter electrode of the analyte sensor is electricallyconnected to node B. When the transcutaneously positionable sensorcontact interstitial fluid, for example, current flow is generated fromthe resulting chemical reaction that takes place. For example, currentwithin the nanoamp (nA) range may be generated and provided to the RCpairs of the electronic circuit.

Concentric electrical contacts (not shown) disposed externally on thehousing of the OBU are each coupled to a respective node A, B, and C inthe electronic circuit shown. In this way, one concentric electricalcontact is provided at the working electrode (node A), anotherconcentric electrical contact at the counter electrode (node C), and yetanother concentric electrical contact between the two RC pairs (node B).

The circuit shown enables measurements to be taken that are indicativeof analyte concentrations detected by the analyte sensor. Vab is thevoltage across the first RC pair (e.g., across nodes A and B) andreflects the current glucose measurement, as filtered based on the R1*C1time constant. Vbc is the voltage across the second RC pair (e.g.,across nodes B and C) and reflects the average glucose value over alonger period of time, as determined by the R2*C2 time constant.Furthermore, the difference between the two voltage readings Vab and Vbcrepresents trend information for the detected analyte concentrations.

In many instances, the measurement accuracy of analyte sensors isdependent upon temperature. As such, in one embodiment, a temperaturesensor is provided with the on-body component to measure bodytemperature at or near the analyte sensor. The temperature reading canthen be used to calibrate the measurement readings accordingly. Thetemperature sensor may be internal or external to the on-body housing.The temperature sensor may also sit above the skin, or be provided as anelectrode running along the analyte sensor to be transcutaneouslyimplanted below the skin. The temperature sensor electrode would then beelectrically coupled to a temperature measurement circuit within theon-body housing. The temperature measurements may be transmitted to theblood glucose meter upon request.

For manufacturability and cost-effectiveness, particularly when theon-body housing is intended to be disposable, it may be desirable toavoid the inclusion of a temperature sensor and/or control circuitry inthe on-body housing. As such, in one embodiment, there is provided ablood glucose meter (or alternative hand-held measurement or analysisinstrument) with a temperature measurement sensor and control system. Insuch embodiment, the temperature measurement sensor is provided on thepermanent hand-held instrument to avoid disposing of the temperaturemeasurement components when the on-body housing is disposed.

In one embodiment, for example, the hand-held instrument (e.g., glucosemeter) may incorporate an infra-red (IR) laser thermometer. When thehand-held instrument is electrically coupled to the on-body housing, theIR beam can shine on a preselected area of the on-body housing andprovide a temperature measurement. The preselected area may in turnprovide a thermally conductive pathway to the skin surface. In anotherembodiment the IR beam can shine directly on the skin surface andprovide a temperature measurement.

In another embodiment, the hand-held instrument (e.g., glucose meter)may incorporate temperature measurement electronics or circuitry formeasuring a voltage produced by a thermistor/thermocouple in the on-bodyhousing. When the hand-held instrument is electrically coupled to theon-body housing, the temperature measurement electronics measure suchvoltage from the thermistor/thermocouple. As such, the temperaturesensor on the on-body housing remains disposable, however, the moreexpensive temperature measurement electronics or circuitry and controlsystems are not disposable.

Embodiments of the present disclosure provide real time analyteconcentration determination from a self-powered sensor as desired orwhen needed by the patient or the user of the analyte monitoring systemby physically touching or contacting the reader or the blood glucosemeter device to the on-body housing placed on the skin surface of theuser or the patient. Based on the physical touching or contacting,embodiments of the present disclosure include acquiring one or moresignals (e.g., voltage levels) associated with the real time analyteconcentration, or one or more signals (e.g., voltage levels) associatedwith monitored analyte concentration trend information (for example, thefluctuation of the monitored analyte concentration over the past threehour period, or over the past one hour period, or over the past fivehour period, or other desirable time periods.

As discussed above, embodiments of the present disclosure includeelectrical contacts on the on-body housing placed on the skin surfaceand in signal communication with the analyte sensor such as self-poweredglucose sensor described above, where the electrical contacts are formedof configured in one or more concentric circles such that anyorientation of the reader or the blood glucose meter relative to theposition of the on-body housing provides for proper contact between theprobes on the reader or the blood glucose meter and the electricalcontacts on the on-body housing to obtain the one or more signalscorresponding to the real time monitored analyte level and/or monitoredanalyte concentration trend information.

Embodiments with the self-powered analyte sensor and the touch-baseddata acquisition described above provide for a compact on-body housingconfiguration as it obviates the need for a data transmission component(e.g., data transmitter such as radio frequency (RF) transmitter, orother communication components) and a power source such as a battery toprovide power to the analyte sensor within the on-body housing. Further,the cost of manufacturing of the components of the analyte monitoringsystem including the on-body component may decrease without the need fordata transmission component nor external power source such as thebattery to power the analyte sensor.

In still another embodiment, where on body component includes an RFtransmitter, monitored analyte concentration data may be captured andautomatically transmitted at a predetermined time interval such as forexample, once per minute, once every 5 minutes and so on, where the realtime monitored analyte concentration data is wirelessly transmitted tothe reader or the blood glucose meter over 1,400 times per day. Suchembodiments also include alarms and/or alerts or notification functionsto warn the user or the patient when the real time monitored analytelevel crosses a threshold or a defined target levels so as to promptlyand effectively take corrective actions.

In one embodiment, a system for determining real time analyteconcentration includes an analyte sensor having a portion in fluidcontact with an interstitial fluid under a skin layer; an on-bodyelectronics including a housing coupled to the analyte sensor andconfigured for positioning on the skin layer, the on-body electronicshousing including a plurality of electrical contacts provided on thehousing; and a data analysis unit having a data analysis unit housingand including a plurality of probes provided on the data analysis unithousing, each of the plurality of probes on the data analysis unithousing configured to electrically couple to the respective one of theplurality of the electrical contacts on the on-body electronics housingwhen the data analysis unit is positioned in physical contact with theon-body electronics; wherein one or more signals on the plurality ofprobes on the data analysis unit housing corresponds to one or more of asubstantially real time monitored analyte concentration level, monitoredanalyte concentration level over a predetermined time period, or a rateof change of the monitored analyte concentration level, or one or morecombinations thereof.

In one embodiment, the analyte sensor is a self-powered sensor. When theself-powered sensor is inserted within interstitial fluid, for example,a current is generated by the sensor and provided to electronics on theOBU—e.g., to the circuit including the RC pairs.

Analytes that may be monitored include, but are not limited to, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine,glucose, glutamine, growth hormones, hormones, ketone bodies, lactate,peroxide, prostate-specific antigen, prothrombin, RNA, thyroidstimulating hormone, and troponin. The concentration of drugs, such as,for example, antibiotics (e.g., gentamicin, vancomycin, and the like),digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may alsobe monitored. In those embodiments that monitor more than one analyte,the analytes may be monitored at the same or different times. In oneembodiment, the analyte sensor is a glucose sensor. In anotherembodiment, the analyte sensor is a ketone sensor.

In yet another embodiment, the plurality of electrical contacts on theon-body electronics housing are concentrically positioned on the on-bodyelectronics housing. In some instances, one concentric electricalcontact is a circular contact that is centered with respect to thecenter of the housing, and the other concentric electrical contacts arering-shaped electrical contacts.

In a further embodiment, each of the plurality of electrical contacts onthe on-body electronics housing are spaced apart by a predetermineddistance relative to each other. The spacing between each adjacentelectrical contact may be independent from one another. In someinstances, each adjacent electrical contact is spaced the same distancefrom the other. In other instances, spacing between adjacent electricalcontacts may vary from one another. It should be appreciated that thespacing implemented should align and correspond with the contacts on thereader to ensure proper contact when the reader is coupled to theon-body housing, irrespective of orientation of the reader on the OBU.

In another embodiment, the data analysis unit includes one of a readeror a blood glucose meter.

In yet another embodiment, the data analysis unit includes an outputunit to output one or more indications related to the one or more of thesubstantially real time monitored analyte concentration level, themonitored analyte concentration level over a predetermined time period,the rate of change of the monitored analyte concentration level, or oneor more combinations thereof.

In a further embodiment, the output unit includes one or more of avisual output unit, an audible output unit, or a vibratory output unit.The output units may facilitate proper operation of the device. In someinstances, the output units provide alarms and/or reminders for theuser—e.g., alarms for high or low glucose readings, rapid rises ordeclines in readings, reminders to take or log readings, reminders totake insulin or other medication, etc. Additional details regardingoutput units may be found in U.S. Provisional Application 61/451,488,the disclosure of which is incorporated herein by reference for allpurposes.

In another embodiment, the predetermined time period includes aboutthree hours. It should be appreciated that the time period may vary indifferent embodiments—e.g., longer or shorter than three hours. In someinstances, the time period may be one or more days.

In yet another embodiment, the on-body electronics includes one or moredata processing components to one or more filter, encode, store, analyzethe one or more signals from the analyte sensor. For example, the OBUmay also include a sensor circuit for obtaining signals from the sensor,a measurement circuit that converts sensor signals to a desired format,and a processing circuit that, at minimum, obtains signals from thesensor circuit and/or measurement circuit for communication to thereader. In some embodiments, the processing circuit may also partiallyor completely evaluate the signals from the sensor for communication tothe reader. The processing circuit often includes digital logiccircuitry. The OBU may also include a data storage unit for temporarilyor permanently storing data from the processing circuit.

In a further embodiment, the one or more data processing componentsdetermines a three hour trend information based on analyte concentrationmonitored by the analyte sensor. It should be appreciated that the timeperiod may vary in different embodiments—e.g., longer or shorter thanthree hours.

In another embodiment, a method includes positioning a portion of ananalyte sensor in fluid contact with an interstitial fluid under a skinlayer; positioning an on-body electronics housing coupled to the analytesensor on the skin layer, the on-body electronics housing including aplurality of electrical contacts provided on the housing; and contactinga plurality of probes provided on a data analysis unit housing to therespective one of the plurality of the electrical contacts on theon-body electronics housing to receive one or more analyte sensorrelated signals corresponding to one or more of a substantially realtime monitored analyte concentration level, monitored analyteconcentration level over a predetermined time period, or a rate ofchange of the monitored analyte concentration level, or one or morecombinations thereof.

Various other modifications and alterations in the structure and methodof operation of this disclosure will be apparent to those skilled in theart without departing from the scope and spirit of the embodiments ofthe present disclosure. Although the present disclosure has beendescribed in connection with particular embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such particular embodiments. It is intended that thefollowing claims define the scope of the present disclosure and thatstructures and methods within the scope of these claims and theirequivalents be covered thereby.

1-55. (canceled)
 56. An apparatus for determining analyte concentration,comprising: an analyte sensor configured to have a portion in fluidcontact with an interstitial fluid under a skin layer, the analytesensor including a working electrode and a counter electrode; and anon-body electronics unit electrically coupled to the analyte sensor andcomprising a housing with a plurality of electrical contacts, a firstresistor-capacitor (RC) pair coupled between a first node and a secondnode, and a second RC pair coupled in series with the first RC pairbetween the second node and a third node, wherein: a first electricalcontact of the plurality of electrical contacts of the on-bodyelectronics unit is coupled to the first node, a second electricalcontact of the plurality of electrical contacts of the on-bodyelectronics unit is coupled to the second node, and a third electricalcontact of the plurality of electrical contacts of the on-bodyelectronics unit is coupled to the third node, and the first node iscoupled to the working electrode and the third node is coupled to thecounter electrode such that a first voltage between the first electricalcontact and the second electrical contact of the on-body electronicsunit represents a real-time current analyte concentration level, asecond voltage between the second electrical contact and the thirdelectrical contact of the on-body electronics unit represents an averageanalyte concentration level over a period of time, and a differencebetween the first voltage and the second voltage represents a real-timetrending of the analyte concentration level.
 57. The apparatus of claim56, wherein the first electrical contact, the second electrical contact,and the third electrical contact are concentrically positioned on thehousing of the on-body electronics unit.
 58. The apparatus of claim 57,wherein the second electrical contact is located in approximately acenter of the first electrical contact and the third electrical contact.59. The apparatus of claim 57, wherein the first electrical contact islocated between the third electrical contact and the second electricalcontact.
 60. The apparatus of claim 57, wherein the third electricalcontact has a greater radius than the first electrical contact.
 61. Theapparatus of claim 56, wherein the analyte sensor is a self-poweredsensor.
 62. The apparatus of claim 56, wherein the analyte sensor is aglucose sensor.
 63. The apparatus of claim 56, wherein the on-bodyelectronics unit includes one or more data processing components toperform one or more of filter, encode, store, or analyze one or moresignals from the analyte sensor.
 64. The apparatus of claim 63, whereinthe one or more data processing components determines trend informationbased on an analyte concentration monitored by the analyte sensor. 65.The apparatus of claim 56, wherein the on-body electronics unit furthercomprises a temperature sensor configured to measure a body temperaturenear the analyte sensor, and the on-body electronics unit is configuredto perform one or more of output the measured body temperature orcalibrate measurement readings in association with an analyteconcentration monitored by the analyte sensor.
 66. A method ofdetermining analyte concentration, comprising: generating a firstvoltage between a working electrode and a counter electrode of ananalyte sensor, the analyte sensor being configured to have a portion influid contact with an interstitial fluid under a skin layer; anddividing the generated first voltage in an on-body electronics unitelectrically coupled to the analyte sensor, the first voltage beingdivided between a first node, a second node, and a third node of theon-body electronics unit, the on-body electronics unit comprising ahousing with a plurality of electrical contacts, a firstresistor-capacitor (RC) pair coupled between the first node and thesecond node, and a second RC pair coupled in series with the first RCpair between the second node and the third node, the plurality ofelectrical contacts including a first electrical contact, a secondelectrical contact, and a third electrical contact; providing a secondvoltage between the first electrical contact and the second electricalcontact, the first electrical contact being coupled to the first node,the second electrical contact being coupled to the second node;providing a third voltage between the second electrical contact and thethird electrical contact, the third electrical contact being coupled tothe third node, wherein the first node is coupled to the workingelectrode and the third node is coupled to the counter electrode suchthat the second voltage between the first electrical contact and thesecond electrical contact of the on-body electronics unit represents areal-time current analyte concentration level, the third voltage betweenthe second electrical contact and the third electrical contact of theon-body electronics unit represents an average analyte concentrationlevel over a period of time, and a difference between the second voltageand the third voltage represents a real-time trending of the analyteconcentration level.
 67. The method of claim 66, wherein the firstelectrical contact, the second electrical contact, and the thirdelectrical contact are concentrically positioned on the housing of theon-body electronics unit.
 68. The method of claim 67, wherein the secondelectrical contact is located in approximately a center of the firstelectrical contact and the third electrical contact.
 69. The method ofclaim 67, wherein the first electrical contact is located between thethird electrical contact and the second electrical contact.
 70. Themethod of claim 67, wherein the third electrical contact has a greaterradius than the first electrical contact.
 71. The method of claim 66,wherein the analyte sensor is a self-powered sensor.
 72. The method ofclaim 66, wherein the analyte sensor is a glucose sensor.
 73. The methodof claim 66, wherein the on-body electronics unit includes one or moredata processing components to perform one or more of filter, encode,store, or analyze one or more signals from the analyte sensor.
 74. Themethod of claim 73, wherein the one or more data processing componentsdetermines trend information based on an analyte concentration monitoredby the analyte sensor.
 75. The method of claim 66, wherein the on-bodyelectronics unit further comprises a temperature sensor configured tomeasure a body temperature near the analyte sensor, and the on-bodyelectronics unit is configured to perform one of more of output themeasured body temperature or calibrate measurement readings inassociation with an analyte concentration monitored by the analytesensor.